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A strong foundation for expanded clinical development

In 2025, Mendus laid the foundation for its updated clinical strategy, aimed at capturing the full potential of vididencel as a post-remission immunotherapy in myeloid blood cancers. 

Because of its mode-of-action that is independent of specific mutations and thanks to a strong safety profile, vididencel can be positioned broadly across different subtypes of acute myeloid leukemia (AML) and in combination with different first-line therapies.

 

Erik Manting, CEO

Following positive phase 2 proof-of-concept data from the ADVANCE II trial, vididencel is currently being studied in the ongoing AMLM22-CADENCE trial as a combination treatment with oral azacitidine for patients in complete remission following intensive chemotherapy. To address the growing patient population treated with the less intensive combination of venetoclax and azacitidine, vididencel will be studied in the DIVA trial, which is currently in preparation to be ready for start mid-2026. Also anticipated in 2026 are the first-in-human data in chronic myeloid leukemia (CML), representing a significant expansion of the addressable patient population. The updated strategy follows the appointment of Prof Dr Tariq Mughal, an internationally acclaimed hemato-oncologist, as Chief Medical and Scientific Officer. Our manufacturing alliance with NorthX Biologics successfully delivered large-scale production of vididencel, as a key milestone for late-stage clinical development and future commercialization. Looking back on 2025, I am proud of our progress in developing vididencel as a robust product that can be manufactured at commercial scale, combined with an attractive clinical strategy that is supported by world-leading clinical experts.

Addressing the need for safe immunotherapy in myeloid blood cancers   

The fact that myeloid blood cancers such as AML and CML are sensitive to the immune system has been demonstrated by the principle of allogeneic hematopoietic stem cell transplantation (alloHSCT), where a donor immune system effectively controls residual disease. Whereas alloHSCT is curative, it is associated with transplant-related mortality and a serious condition called graft-versus-host disease (GvHD). This creates a need for safer immunotherapies, particularly for patients that cannot undergo alloHSCT because of the associated risks or lack of a suitable donor. Mendus has developed vididencel as an active immunotherapy, designed to safely stimulate the patient’s own immune system to eliminate residual cancer cells.

At the ASH 2025 conference, Mendus presented updated results from the ADVANCE II Phase 2 trial. The trial addresses a high-risk AML population, based on the presence of persistent measurable residual disease (MRD) following intensive chemotherapy (IC). At a median follow-up of 55 months, 13 out of 20 patients treated with vididencel were still alive, with 8 patients already having passed 5-year follow-up and an estimated 5-year survival of 63%, versus less than 30% with standard of care. The continued positive data support the updated clinical strategy to position vididencel broadly as a first-line post-remission therapy in AML. Vididencel is currently being studied in the ongoing Australian AMLM22-CADENCE randomized Phase 2b trial in combination with oral azacitidine to improve relapse-free and overall survival following IC independent of MRD status. The study is on track to enroll the first 20 patients in the first half of 2026. To treat AML patients classified as “unfit” for standard IC, a less intensive therapy comprising venetoclax combined with azacitidine (Ven+Aza) has been approved. Increasing clinical evidence supports the expanding use of Ven-Aza to also treat newly diagnosed “fit” patients. To adapt to this evolution of first line treatment, vididencel will be studied in combination with Ven+Aza in the Phase 1b DIVA trial, which is expected to start mid-2026. The results from the CADENCE and DIVA trials, combined with the evolving treatment landscape, will determine the optimal path to market for vididencel as a broadly applicable post-remission immunotherapy in AML.

With around 300,000 patients in the US and Europe only, CML represents a significant expansion of the addressable patient population for vididencel. Because CML is a chronic disease that can be effectively controlled with targeted therapy based on tyrosine kinase inhibitors (TKIs), overall survival expectations for chronic-phase (CP) CML patients today are close to the general population. However, the large impact on quality of life and costs associated with continuous TKI treatment have shifted attention to treatment-free remissions (TFR). Vididencel can support TFR by stimulating immunity against residual disease, allowing patients to safely and more successfully stop their TKI treatment. The VITAL-CML Phase 1 trial is expected to start in the first half of 2026 and will focus on patients with a suboptimal response to TKIs. Subject to positive initial safety data, the VITAL-TFR2 Phase 2a trial will commence towards the end of the year and evaluate vididencel in the second TFR setting, for CP-CML patients with a previously failed TFR attempt.

Other programs

In its earlier-stage pipeline, Mendus reported positive 2-year follow-up data from the ALISON Phase 1 trial in high-grade serous ovarian cancer. The data confirmed that vididencel-induced tumor-directed immune responses were associated with prolonged progression-free survival. No product-related serious side effects were observed, positioning vididencel as a safe immunotherapy that can be combined with other therapeutic modalities. The United States Patent and Trademark Office (USPTO) granted a patent validating the application of vididencel in ovarian cancer. In 2025, Mendus also reported progress in the preclinical pipeline focused on the expansion of NK cells and tumor-infiltrating lymphocytes (TILs) for therapeutic purposes. Mendus has an ongoing preclinical collaboration with an international biopharmaceutical company to study vididencel in combination with a targeted therapy in AML and will seek additional partnerships to develop its earlier-stage pipeline opportunities.

Conclusion and outlook

Vididencel addresses a high unmet need for safe immunotherapy in myeloid blood cancers. The updated clinical strategy for which we laid the foundation in 2025 will allow us to explore the full potential of vididencel in AML and potentially open up CML as a large additional indication. With multiple ongoing and upcoming trials, Mendus is well-positioned to deliver multiple relevant clinical milestones in 2026. Thank you for your continued commitment and support.

 

Erik Manting, Ph.D.

Chief Executive Officer

 

*Published on April 17th 2026